---
kind: "section"
citation: "21 C.F.R. § 814.15"
title: "21"
number: "814.15"
heading: "Research conducted outside the United States."
url: "https://uscodex.org/cfr/21/814.15"
---

# §814.15. Research conducted outside the United States.

- (a) **Data to support PMA.** If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in [§ 812.28](/cfr/21/812.28.md) of this chapter, as applicable.
- (b) **As sole basis for marketing approval.** A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:
  - (1) The foreign data are applicable to the U.S. population and U.S. medical practice;
  - (2) The studies have been performed by clinical investigators of recognized competence; and
  - (3) The data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.
- (c) **Consultation between FDA and applicants.** Applicants are encouraged to meet with FDA officials in a “presubmission” meeting when approval based solely on foreign data will be sought.

## Notes

### Amendments

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 83 FR 7387, Feb. 21, 2018]

### Authority

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

### Source

Source: 51 FR 26364, July 22, 1986, unless otherwise noted.

### Amendments

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 83 FR 7387, Feb. 21, 2018]